Global medical device company assisted in relation to the suspension by Health Canada of its medical device licence

Fasken Martineau was retained by a major medical device manufacturer to assist with various aspects relating to the suspension by Health Canada of its medical device licence (marketing authorization) as well as various Health Canada inspections of its manufacturing sites (in Canada and the U.S.) and three (3) worldwide global product recalls in more than 90 countries. Fasken Martineau advised on the related legal and tactical aspects and represented the client in various Health Canada hearings, inspections and investigations. As a result of Fasken’s advocacy and strategic initiatives, Health Canada accepted the company’s position and withdrew its intention to suspend the license. Fasken Martineau also assisted in the alignment of the global strategy and advised in the design and implementation of various recall plans and product withdrawals.